ALM Validation Lead

Alm Validation Lead

About the role As an ALM Validation Lead, you will make an impact by leading validation and testing initiatives across life sciences systems, ensuring compliance with global regulatory standards while driving digital transformation. You will be a valued member of the Quality Engineering and Assurance team and work collaboratively with cross-functional stakeholders including regulatory, compliance, and business teams.

In this role, you will:

• Develop and implement comprehensive validation and test strategies aligned with FDA, EMA, and GxP standards, supporting the transition to CSA.
• Define objectives and priorities for validation and testing across clinical, regulatory, and manufacturing systems, with a focus on digital transformation and paperless execution.
• Lead end-to-end validation and testing phases for systems supporting drug development, clinical data management, regulatory submissions, and digital documentation.
• Collaborate with stakeholders to establish validation protocols and ensure adherence to CSV/CSA principles.
• Drive adoption and transition from paper-based processes to ALM/Test Management tools, ensuring regulatory compliance.

Work model: We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role's business requirements, this is a hybrid position requiring 23 days a week onsite in Foster City, CA. Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.

What you need to have to be considered:

• 10+ years of experience in testing and validation within the pharmaceutical or life sciences domain, including 2+ years in a management role.
• Expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Strong knowledge of ALM Test Management tools.
• Deep understanding of FDA, EMA, GxP, and 21 CFR Part 11 requirements; familiarity with GAMP standards.
• Solid project management skills with experience managing complex test programs and cross-functional teams.
• Excellent communication and reporting skills, including stakeholder engagement and documentation for audits.
• Bachelor's degree in Computer Science, Life Sciences, or a related field; advanced degree preferred.

These will help you stand out:

• Experience in Salesforce implementation and testing.
• Exposure to test automation frameworks and tools.
• Experience managing data testing initiatives including ETL, Data Warehousing, Data Lakes, Hadoop, and data transformation techniques.
• Certifications such as ISTQB, PMP, or relevant regulatory compliance credentials.

• Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship

We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.

Salary and other compensation: The annual salary for this position is between $71,100 to $112,500 depending on experience and other qualifications of the successful candidate. This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.

Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:

• Medical/Dental/Vision/Life Insurance
• Paid holidays plus Paid Time Off
• 401(k) plan and contributions
• Long-term/Short-term Disability
• Paid Parental Leave
• Employee Stock Purchase Plan

What we offer:

• The chance to work with impact. Here, you're empowered to bring your biggest thinking to help our company and clients improve everyday life.
• Ownership over your career. Stay at the top of your game through our award-winning learning and development ecosystem. And when your ambitions change or we offer new opportunities, we help you pivot by providing reskilling, on-the-job learning and guidance to find new roles that might be a better fit.
• The opportunity to thrive on a high caliber team with heart. We celebrate each other's experiences and perspectives and promote a sense of belonging through our affinity groups and diversity and inclusion initiatives.
• A comprehensive total rewards package, including a competitive salary and pension plan with matching contributions.
• Flexible health and financial benefits to support you and your eligible dependents from day one.
• True work-life balance. Be at your best through paid time off, flexible work arrangements, volunteering opportunities, social events, and so much more.

About us Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World's Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital.

Other employment-related information Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, provincial or local laws.

If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email CareersNA2@cognizant.com with your request and contact information.

Language requirements vary depending on roles, but we ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you'll deliver services to and collaborate with stakeholders outside the province who may not speak French.